pharmadog
News
when
  • Latest
  • Archive
by source
  • All Sources
  • Sources Page
Jobs
department
  • Clinical
  • Regulatory
  • Medical Affairs
  • Commercial
  • R&D / Discovery
  • Biostatistics / Data
  • Manufacturing / CMC
  • Market Access
therapeutic area
  • Oncology
  • Immunology
  • Neuroscience
  • Cardiovascular
  • Metabolic
  • Rare Disease
  • Infectious Disease
location & type
  • Remote Only
  • US Only
  • California
  • Massachusetts
  • Internships
  • Phase 3 Roles
  • All Jobs →
Sign InSubscribe
pharmadog

fetch the data · sniff the signal

Discover
  • Jobs
  • News
Hubs
  • Topics
  • Patent cliff
  • Publications
Tools
  • Compare
  • Search
  • Bookmarks
Trust
  • About
  • Sources
  • Contact
Legal
  • Privacy
  • Terms
  • Pricing

© 2026 pharmadog.xyz

made by humans and a good dog

  • home
  • jobs
  • news
  • search
pharmadog news

Browse

711 stories matching this filter · ← front page

★ save view↓export CSV
rangeto
sort
recentoldestsourcealpha
source
STAT1212Endpoints918BioPharma Dive354BioSpace335Fierce Biotech314onclive165raps111globenewswire health
therapy area
allOncology8116Rare Disease1931Cardiology1874Immunology1548Hematology1353Pulmonology1254Vaccines
  • AbCellera’s antibody ABCL635 cuts hot flash frequency in early trial, outperforms oral competitors
    AbCellera Biologics reported that its investigational antibody ABCL635 markedly reduced the number of moderate and severe hot flashes in post‑menopausal women during a Phase 1/2 study. At week four…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Vaderis raises $152M Series B to launch Phase 3 trial of engasertib for hereditary hemorrhagic telangiectasia
    Vaderis Therapeutics, a Swiss biotech, announced it has closed an oversubscribed $152 million Series B financing round. The new capital will fund the initiation of a Phase 3 study, named HEROIC, e…
    BioSpace · 1mo agoDealPositive↗ source
← prev
page 12 of 29
next →
73
fda recalls71
fda medwatch62
fda press38
1253
Psychiatry & CNS887
Ophthalmology520
Pain501
Endocrinology & Metabolism494
Infectious Disease457
  • FDA issues complete response letter rejecting ITM Isotope's radiopharma therapy over manufacturing concerns
    FDA sent a complete response letter rejecting the NDA for ITM Isotope's investigational radiopharmaceutical, citing manufacturing and third-party facility issues. The agency said there were no con…
    BioSpace · 1mo agoCRLNeutral↗ source
  • Scholar Rock pulls Indiana fill-finish plant from SMA therapy filing after FDA flags violations
    Scholar Rock has removed Novo Nordisk's former Catalent fill‑finish facility in Bloomington, Indiana, from its regulatory filing for a spinal muscular atrophy therapy after the FDA classified the p…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
    Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product. The company said the contaminati…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Austria launches up to €100 million anchor investment for growth fund, aiming to channel half‑billion euros into biotech
    Austria's government announced a new national Startup & Scaleup Fund as part of the 2027/2028 budget, with an anchor investment of up to €100 million. The public money is designed to attract priva…
    BioSpace · 1mo agoPositive↗ source
  • Silence causes uproar in rare blood cancer space as data sets high bar for competitors
    The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Taked…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • FDA rejects ITM radiopharma therapy while WHO defends immunization schedules
    The U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…
    raps · 1mo agoRegulatoryNeutral↗ source
  • PIC/S releases revised guide on qualification and validation studies for pharma manufacturing
    PIC/S has issued an updated guideline that outlines general principles for qualification and validation studies in pharmaceutical manufacturing facilities. The new guide is intended for both inspe…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Tenax Therapeutics' heart failure drug TNX-103 misses primary endpoint in Phase 3, shares plunge 85%
    Tenax Therapeutics announced that its investigational heart failure drug TNX-103 failed to meet the primary efficacy endpoint in the Phase 3 LEVEL trial. The trial, which enrolled patients with pu…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Eli Lilly's $3.8 B acquisition of AtaiBeckley signals growing confidence in psychedelics for depression
    Psychedelics are being touted as a potential solution for patients who still struggle to find lasting relief from existing FDA‑approved psychiatric medicines. The article notes that many individual…
    BioSpace · 1mo agoDealPositive↗ source
  • Jazz Pharma to acquire Actio Biosciences for up to $1.3 billion, adding experimental KCNT1 epilepsy drug
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, paying $820 million in cash with up to $500 million in milestone payments. The deal is expected to close by the end of the year.…
    BioSpace · 1mo agoDealPositive↗ source
  • Biogen’s ALS drug shows symptom improvement in some patients three years after approval
    Biogen’s antisense therapy tofersen, marketed as Qalsody, received FDA approval three years ago as the first treatment to target a genetic form of ALS linked to the SOD1 gene. Since then, a number…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • BMS commits $2.3 billion to build modular manufacturing campus in Houston, creating 2,500 jobs
    Bristol Myers Squibb announced a $2.3 billion investment to construct a new manufacturing campus in Houston, Texas. The site will cover about 600,000 square feet and is designed to be modular, allo…
    BioSpace · 1mo agoPositive↗ source
  • Sionna’s Phase 2a CF trial fails, shares plunge as Vertex’s Trikafta remains standard of care
    Sionna Therapeutics announced that its Phase 2a cystic fibrosis trial of the NBD1 stabilizer SION-719 did not meet its primary endpoint, sending the company’s stock down more than 90% in pre‑market…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Psychedelic firms Definium and Compass poised for key data releases
    Investors and analysts are focusing on two psychedelic companies as they approach pivotal milestones. Definium Therapeutics is set to release Phase 3 Voyage data for its single-dose oral LSD candi…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • AstraZeneca and CSPC launch joint venture to build biologics plant in Shijiazhuang
    AstraZeneca and China's CSPC Pharmaceutical have formed a joint venture to construct a biologics manufacturing facility in Shijiazhuang. The agreement follows AstraZeneca's pledge earlier this year…
    BioSpace · 1mo agoDealPositive↗ source
  • BioMarin drops BMN 401 after Phase 3 trial misses clinical endpoints, ending $270M Inozyme asset
    BioMarin announced it will stop development of BMN 401, an enzyme replacement therapy acquired in its $270 million purchase of Inozyme Pharma. The decision follows the Phase 3 ENERGY trial in pati…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • AGC Biologics targets in-vivo gene therapies with stable producer lines and next-gen purification
    The industry is moving from ex vivo to in vivo gene delivery, a change that forces viral vector manufacturers to rethink scale, purity, cell lines and analytical methods. In in vivo approaches the…
    BioSpace · 1mo agoPositive↗ source
  • BMS's Cobenfy faces market hurdles as side effects limit uptake, MapLight eyes opportunity
    The FDA approved Bristol Myers Squibb's Cobenfy in 2024, marking the first novel schizophrenia treatment in 35 years and raising hopes for a new therapeutic approach. Since its launch, the drug ha…
    BioSpace · 1mo agoNegative↗ source
  • Abiomed and Oscor advise correction of Impella catheter introducers due to leakage risk
    Abiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps. The issue involves 14Fr and 23Fr introducer kits,…
    fda medwatch · 1mo agoCRLNeutral↗ source
  • FDA issues warning letters to Indian OTC drugmaker over falsified logbooks and cites GMP lapses at two other firms
    The FDA sent warning letters to an over‑the‑counter drug manufacturer in India after discovering the company had submitted falsified production logbooks. The agency also cited two additional OTC m…
    raps · 1mo agoRegulatoryNegative↗ source
  • FDA issues warning letters to Indian OTC drugmaker for falsified logbooks and to two others for GMP testing lapses
    The U.S. Food and Drug Administration sent a warning letter to an over‑the‑counter drugmaker in India after discovering that the company had submitted falsified logbooks to the agency. In addition…
    raps · 1mo agoRegulatoryNegative↗ source